Maintenance therapy using azathioprine or mycophenolate mofetil, helps consolidate remission and prevent relapse after the initial control of lupus nephritis.
The 36-month, randomized, double-blind, double-dummy, phase 3 study compared oral mycophenolate mofetil (2 g per day) and oral azathioprine (2 mg per kilogram of body weight per day), plus placebo in patients who met response criteria during a 6-month induction trial.
The primary efficacy end point included time to treatment failure, which was defined as death, end-stage renal disease, doubling of the serum creatinine level, renal flare, or rescue therapy for lupus nephritis.
Secondary assessments had been the time to the individual components of treatment failure and adverse events.
The data demonstrated that Mycophenolate mofetil was superior to azathioprine in terms of the primary end point, time to treatment failure, and with respect to time to renal flare and time to rescue therapy.